Percentage of Participants With Adverse Events (AEs) and Graded Laboratory Abnormalities [ Time Frame: Up to 48 weeks plus 30 days ] [ Designated as safety issue: No ]

This outcome measure assessed the safety and tolerability profile of Stribild. Treatment-emergent adverse events (AEs) and graded laboratory abnormalities occurring from baseline up to 30 days following the last dose of study drug were summarized.

This study will evaluate the efficacy of Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF)) single-tablet regimen (STR) after switching from a regimen consisting of raltegravir plus Truvada® (FTC/TDF) at baseline in maintaining HIV-1 RNA < 50 copies/mL at Week 12 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of Stribild over 24 and 48 weeks of treatment.

Virologically stable on the current first antiretroviral regimen consisting only of raltegravir twice daily plus FTC/TDF continuously for ≥ 6 months preceding the screening visit and

have documented undetectable plasma HIV-1 RNA levels ≥ 6 months preceding the screening visit (measured at least twice using the same assay) and

have never experienced two consecutive HIV-1 RNA above detectable levels after first achieving a confirmed HIV-1 RNA level below detectable levels on the first regimen

HIV-1 RNA < 50 copies/mL at the screening visit

Have a genotype prior to starting initial antiretroviral therapy and have no known resistance to any of the study agents at any time

Normal ECG

Hepatic transaminases ≤ 5 x upper limit of normal (ULN)

Total bilirubin ≤ 1.5 mg/dL

Adequate hematologic function

Serum amylase ≤ 5 x ULN

Estimated glomerular filtration rate ≥ 70 mL/min

Females of childbearing potential must agree to utilize highly effective contraception methods or be non-heterosexually active, practice sexual abstinence or have a vasectomized partner from screening throughout the duration of the study period and for 30 days following the last dose of study drug

Females who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing

Males must agree to utilize a highly effective method of contraception during heterosexual intercourse from the screening visit, throughout the duration of the study and for 30 days following discontinuation of investigational medicinal product or must be non heterosexually active, practice sexual abstinence, or be vasectomized

Exclusion Criteria:

New AIDS defining condition diagnosed within the 21 days prior to screening

Participation in any other clinical trial without prior approval from the sponsor

Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study

Any other clinical condition or prior therapy that would make the individual unsuitable for the study or unable to comply with the dosing requirements

Receiving ongoing therapy or anticipated to need to initiate drugs or herbal/natural supplements during the study that are contraindicated or not recommended for use, including drugs not to be used with Stribild; or individuals with known allergies to the excipients of the Stribild single tablet regimen

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects